Live Video Webcast: Advent of Oncology Monoclonal Antibody Biosimilars ‒ A European Perspective
Live Video Webcast: Advent of Oncology Monoclonal Antibody Biosimilars ‒ A European Perspective


Click Here for Live Webcast!

October 27, 2017
2:00PM GMT

 

Overview

The European Medicines Agency (EMA) has approved more than 20 biosimilars since developing guidelines and recommendations for evaluation of these agents. As biologic products lose patent exclusivity, and more biosimilar monoclonal antibodies receive regulatory approval, it will be necessary for healthcare providers to understand the key concepts and issues involved in biosimilar development so they can make informed decisions when adopting these agents into their clinical practice. This is especially critical because multiple biosimilars of the same product are likely to become available. It is also important to be clear about whether a specific product has been evaluated through a rigorous evaluation procedure, based on the criteria defined in the EMA biosimilar guidelines, and for prescribers to understand what happens when a biosimilar receives a designation of “interchangeable” with the originator and when substitution may occur, as these designations/policies may impact patient outcomes.

Advent of Oncology Monoclonal Antibody Biosimilars ‒ A European Perspective is designed as a live video webcast, created and broadcast in real-time to a European audience. It is designed to educate European pharmacists and physicians about the advantages of the emerging curative oncology biosimilars in terms of their potential to reduce the acquisition cost of cancer drugs, thereby increasing affordability and patient access.

Target Audience

The live portion of this educational initiative is directed toward oncology health care practitioners based outside the United States, including medical oncologists, surgical oncologists, radiation oncologists, and pharmacists involved or interested in the treatment of cancers. The enduring components of this educational initiative are targeted to the broader audience of European pharmacists and physicians.

Learning Objectives

  • Explain the importance of analytical studies in development and regulatory approval of biosimilars.
  • Describe the concepts of immunogenicity and extrapolation of indications based on evaluation of the totality of the evidence and mechanism of action rationale.
  • Appraise the importance of pharmacoeconomics and access to biological oncology medicines in Europe.
  • Discuss the potential clinician-, nurse-, pharmacist-, and patient-specific issues relating to the suboptimal use of biosimilars and strategies to mitigate them.
  • Summarize current and emerging data on oncology monoclonal antibody biosimilars and their potential to enable optimal combination therapy.

Program Chairs:

Hope S. Rugo, MD
Professor of Medicine
Director, Breast Oncology and Clinical Trials Education
University of California San Francisco
Helen Diller Family Comprehensive Cancer Center
San Francisco, CA
 


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